BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL SAFETY SCALPEL COMPONENT OF TRAY

    MDR report key: 2559993 · Received April 24, 2012

    Report

    Report Number
    3005011024-2012-00001
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    February 25, 2012
    Report Date
    March 27, 2012
    Manufacturer
    MERIT MEDICAL
    Product Code
    GDX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SURGERY, AS THE SURGEON MOVED THE SCALPEL BLADE TOWARD THE SCRUB TABLE, WHILE PRESSING THE BUTTON TO RETRACT THE BLADE, THE BLADE EJECTED FROM THE SCALPEL HOUSING. HOSP CLAIMS BLADE EJECTED WITH A LOT OF FORCE. THERE WAS NO INJURY TO ANY SURGICAL PERSONNEL OR THE PT. DEROYAL INDUSTRIES, INC IS THE MFR OF THE ANGIOGRAPHY TRAY BUT THE SAFETY SCALPEL INVOLVED IN THIS REPORT IS MFG BY MERIT MEDICAL. THE SAFETY SCALPEL IS A COMPONENT OF THE DEROYAL ANGIOGRAPHY TRAY. SEVERAL SAMPLES OF DIFFERENT SAFETY SCALPELS FROM DIFFERENT LOTS DID NOT PRODUCE ANY BLADE RETRACTION MALFUNCTIONS WHEN TESTED.

    Description of Event or Problem · 1

    DURING SURGERY, AS THE SURGEON MOVED THE SCALPEL BLADE TOWARD THE SCRUB TABLE, WHILE PRESSING THE BUTTON TO RETRACT THE BLADE, THE BLADE EJECTED FROM THE SCALPEL HOUSING. HOSPITAL CLAIMS BLADE EJECTED WITH A LOT OF FORCE. THERE WAS NO INJURY TO ANY SURGICAL PERSONNEL OR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL SAFETY SCALPEL COMPONENT OF TRAY SAFETY SCALPEL GDX MERIT MEDICAL 89-7387 24271355

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR